PUBLIC SUMMARY DOCUMENT
Product:SenSura Mio One Piece Soft Convexity Drainable
Applicant:Coloplast Pty Ltd
Date of SPAP Meeting:17 &18 August 2015
- Proposed Listing on the Stoma Appliance Scheme
The applicant, Coloplast Pty Ltd, sought listing of the SenSura Mio One Piece Soft Convexity Drainable Pouch in subgroup 2(b) of the Stoma Appliance Scheme (SAS) Schedule. The product, including eight variants,was proposed for listed at the benchmark unit price of $6.373, with a maximum monthly quantity of 30 units.
- Comparator
The applicant nominated DansacNovaLife One Open Soft Convexity (SAS code 80000M) as the comparator. This product is currently listed at the unit price of $6.578, inclusive of a $0.205 price premium.
- Background
This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.
- Clinical Place for the Product
The proposed product provides an alternative for users requiring a one-piece convex drainable pouch.
- SPAP Comment
Clinical Analysis
The Panel noted that the proposed product is an updated version of the currently listed SenSura One Piece with Convexity (SAS code 9851L). The difference between the two products is the greater adhesion, flexibility and body fit technology.
The Panel noted that DansacNovaLife One Open Soft Convexity (SAS code 80000M) was not a suitable comparator, as this product has a price premium for the AF300 filter. The Panel agreed that the applicant should have used one of their own products as a comparator such as the ColoplastAlterna or SenSura Mio.
The applicant stated that the product is expected to deliver additional value to that of existing products and a price premium may be appropriate. However, due to evidence not yet being available they sought listing at the benchmark price. SPAP noted this statement.
Without additional evidence the SenSura Mio One Piece Soft Convexity Drainable is considered to be equivalent to products currently available at the benchmark price in subgroup 2(b), therefore listing on a cost minimisation basis was considered appropriate.
Economic Analysis
Not undertaken.
Financial Analysis
Listing of this product is recommended on a cost minimisation basis compared with the notional benchmark product in subgroup 2(b) of the SAS Schedule. It is therefore unlikely that there would be any budgetary impact for the SAS as a consequence of listing this product under the conditions requested by the applicant.
- SPAP Recommendation
The SPAP recommended that SenSura Mio One Piece Soft Convexity Drainable, be listed in subgroup 2(b) of the SAS Schedule at a unit price of $6.373, including eight variants, with a maximum monthly quantity of 30 units.
- Context for Decision
The SPAP helps decide whether stoma products should be subsidised and, if so, the conditions of their subsidisation in Australia. It considers submissions in this context. An SPAP decision not to recommend listing or changes to a listing does not represent a final SPAP view about the merits of a particular stoma product. A company can resubmit to the SPAP following a decision not to recommend listing or changes to a listing. The SPAP is an advisory committee and as such its recommendations are non-binding on Government. All SPAP recommendations are subject to Cabinet/Ministerial approval.
- Applicant’s Comment
ColoplastPty Ltd respect and agree with the SPAP recommendation.
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